Clinical study design is the formulation of trials and experiments, as well as observational studies in medical, clinical and other types of research (e.g., epidemiological) involving human beings. The goal of a clinical study is to assess the safety, efficacy, and / or the mechanism of action of an investigational medicinal product (IMP) or procedure, or new drug or device that is in development, but potentially not yet approved by a health authority (e.g. Food and Drug Administration). It can also be to investigate a drug, device or procedure that has already been approved but is still in need of further investigation, typically with respect to long-term effects or cost-effectiveness. Some of the considerations here are shared under the more general topic of design of experiments but there can be others, in particular related to patient confidentiality and ethics. Randomized controlled trial Blind trial Non-blind trial Adaptive clinical trial Platform Trials Nonrandomized trial (quasi-experiment) Interrupted time series design (measures on a sample or a series of samples from the same population are obtained several times before and after a manipulated event or a naturally occurring event) - considered a type of quasi-experiment

  1. Descriptive Case report Case series Population study
  2. Analytical Cohort study Prospective cohort Retrospective cohort Time series study Case-control study Nested case-control study Cross-sectional study Community survey (a type of cross-sectional study) Ecological study When choosing a study design, many factors must be taken into account. Different types of studies are subject to different types of bias. For example, recall bias is likely to occur in cross-sectional or case-control studies where subjects are asked to recall exposure to risk factors. Subjects with the relevant condition (e.g. breast cancer) may be more likely to recall the relevant exposures that they had undergone (e.g. hormone replacement therapy) than subjects who don't have the condition.
À propos de ce résultat
Cette page est générée automatiquement et peut contenir des informations qui ne sont pas correctes, complètes, à jour ou pertinentes par rapport à votre recherche. Il en va de même pour toutes les autres pages de ce site. Veillez à vérifier les informations auprès des sources officielles de l'EPFL.
Cours associés (8)
MATH-352: Causal thinking
This course will give a unified presentation of modern methods for causal inference. We focus on concepts, and we will present examples and ideas from various scientific disciplines, including medicin
DH-411: Design research for digital innovation
How can we turn digital technologies and data into meaningful user experiences? How can we face societal issues raised by digital evolution? This course proposes an immersion in design research, user
MATH-493: Applied biostatistics
This course covers topics in applied biostatistics, with an emphasis on practical aspects of data analysis using R statistical software. Topics include types of studies and their design and analysis,
Afficher plus
Séances de cours associées (20)
Peptide Thérapeutique
Explore le développement et les avantages des thérapies peptidiques, y compris la conversion en peptidomimétiques et la synthèse de peptides en phase solide.
Essai clinique randomisé de Greenatectomy Brewed
Discute de l'essai clinique randomisé de la verdectomie brassée et des sujets connexes.
Remodelage mécanique des tissus
S'intéresse à la biomécanique osseuse, à l'adaptation à différentes échelles de temps et à l'influence du stimulus mécanique sur l'évolution de la densité osseuse.
Afficher plus
Publications associées (87)

Using Negative Control Populations to Assess Unmeasured Confounding and Direct Effects

Mats Julius Stensrud

Sometimes treatment effects are absent in a subgroup of the population. For example, penicillin has no effect on severe symptoms in individuals infected by resistant Staphylococcus aureus, and codeine has no effect on pain in individuals with certain polym ...
Lippincott Williams & Wilkins2024

Iron-carbohydrate complexes treating iron anaemia: Understanding the nano-structure and interactions with proteins through orthogonal characterisation

Antonia Neels, Marianne Liebi, Tiberiu Totu

Intravenous (IV) iron-carbohydrate complexes are widely used nanoparticles (NPs) to treat iron deficiency anaemia, often associated with medical conditions such as chronic kidney disease, heart failure and various inflammatory conditions. Even though a ple ...
Elsevier2024
Afficher plus
Unités associées (1)
Concepts associés (7)
Hierarchy of evidence
A hierarchy of evidence, comprising levels of evidence (LOEs), that is, evidence levels (ELs), is a heuristic used to rank the relative strength of results obtained from experimental research, especially medical research. There is broad agreement on the relative strength of large-scale, epidemiological studies. More than 80 different hierarchies have been proposed for assessing medical evidence. The design of the study (such as a case report for an individual patient or a blinded randomized controlled trial) and the endpoints measured (such as survival or quality of life) affect the strength of the evidence.
Adaptive design (medicine)
In an adaptive design of a clinical trial, the parameters and conduct of the trial for a candidate drug or vaccine may be changed based on an interim analysis. Adaptive design typically involves advanced statistics to interpret a clinical trial endpoint. This is in contrast to traditional single-arm (i.e. non-randomized) clinical trials or randomized clinical trials (RCTs) that are static in their protocol and do not modify any parameters until the trial is completed.
Quasi-experiment
A quasi-experiment is an empirical interventional study used to estimate the causal impact of an intervention on target population without random assignment. Quasi-experimental research shares similarities with the traditional experimental design or randomized controlled trial, but it specifically lacks the element of random assignment to treatment or control. Instead, quasi-experimental designs typically allow the researcher to control the assignment to the treatment condition, but using some criterion other than random assignment (e.
Afficher plus

Graph Chatbot

Chattez avec Graph Search

Posez n’importe quelle question sur les cours, conférences, exercices, recherches, actualités, etc. de l’EPFL ou essayez les exemples de questions ci-dessous.

AVERTISSEMENT : Le chatbot Graph n'est pas programmé pour fournir des réponses explicites ou catégoriques à vos questions. Il transforme plutôt vos questions en demandes API qui sont distribuées aux différents services informatiques officiellement administrés par l'EPFL. Son but est uniquement de collecter et de recommander des références pertinentes à des contenus que vous pouvez explorer pour vous aider à répondre à vos questions.